Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer

Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer (SIRIRALS-trial): a Randomized Controlled Trial

The current hypothesis is that robotic-assisted surgery results in a reduced systemic and peritoneal inflammatory response (SIRS) compared to laparoscopic surgery in the treatment of colon cancer. The purpose is to evaluate differences in the peritoneal and systemic inflammatory response in robot-assisted and laparoscopic surgery of patients undergoing resection for colon cancer in a randomized, blinded controlled trial.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Inflammatory Response Syndrome; Inflammation; Colon Cancer; Colonic Neoplasms; Laparoscopy; Robotic Surgical Procedures; Peritoneal Inflammation
• Intervention / Treatment: Procedure: Robotic-assisted colectomy; Procedure: Conventional laparoscopic colectomy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pedja Cuk, MD; Phone Number: +4579970000; Email: pedja.cuk@rsyd.dk

Study Locations

• Denmark
  • Aabenraa, Denmark
    • Hospital of Southern Denmark
    • Contact: Pedja Cuk, MD
    • Principal Investigator: Pedja Cuk, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• Elective robotic-assisted or laparoscopic surgery for right-sided, left-sided and sigmoid colon cancer
• Aged ≥ 18
• ASA-score ≤ 3
• Tumor-stage (Tx-T4a)
• Endoscopic suspected colon cancer
• Histological verified adenocarcinoma, signet ring cell carcinoma, undifferentiated cancer, medullary carcinoma, or another malignant tumor type originating from colon
• Patients must give informed written consent
• Patients must be able to understand Danish language

Exclusion criteria

• Carcinoma of the transverse colon or synchronous colorectal cancer
• Previous history of colon cancer
• Previous open major abdominal surgery with exception of open appendectomy and cholecystectomy.
• Metastatic disease
• Pregnancy
• History of psychiatric or addictive disorder that would prevent the patient from participating in the trial
• Emergency colon surgery
• Co-existing inflammatory bowel disease
• Co-existing immunological disease that requiring ingestion of systemic immunomodulatory drugs (DMARD - disease modifying anti-rheumatic drugs), corticosteroids and biologic disease-modifying anti-rheumatic drugs.
• Daily consumption of NSAID drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Robotic-assisted surgery; Patients undergoing robotic-assisted colectomy for colonic neoplasm	Procedure: Robotic-assisted colectomy; Robotic-assisted colectomy performed by usage of da Vinci Xi robotic technology
ACTIVE_COMPARATOR: Laparoscopy; Patients undergoing conventional laparoscopic colectomy for colonic neoplasm	Procedure: Conventional laparoscopic colectomy; Conventional laparoscopic colectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in levels of systemic inflammatory response expressed by CRP and IL-6 in serum between the two groups	CRP (mg/L), IL-6 (pg/mL)	Baseline and postoperative (day 1-3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in levels of systemic inflammation in serum between the two groups	The cytokine levels are expressed by: Eotaxin, Eotaxin-3, GM-CSF, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-7, IL-8, IL-8 (HA), IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, TARC, TNF-α, TNF-β, VEGF-A and IL-1RA. All cytokines are measured in pg/mL	Baseline and postoperative (day 1-3)
Differences in number of patients with postoperative surgical and medical complications (30 days) according to Clavien-Dindo classification and Comprehensive Complication Index (CCI)	Number of complications obtained from medical records	30 days
Differences in intraoperative blood loss	Measured in mL	1 day
Conversion rate to open surgery	Number of conversions to open surgery	1 day
Length of surgery (total anesthesia time)	Measured in minutes	1 day
Length of surgery (total surgical time)	Measured in minutes	1 day
Lymph node yield	Pathological examination of lymph nodes	14 days
Length of hospital stay	Measured in days	14 days
Postoperative pain	Measured by VAS-scale	Baseline and postoperative (day 1-3 and 14)
Time to first flatus	Measured in hours	Postoperative (day 1-3)
Time to first bowel movement	Measured in hours	Postoperative (day 1-3)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of peritoneal inflammatory response in peritoneal fluid	Levels of cytokines are expressed by: Eotaxin, Eotaxin-3, GM-CSF, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, TARC, TNF-α, TNF-β, VEGF-A as well as IL-1RA and CRP. All cytokines are measured in pg/mL, CRP measured in mg/L	Postoperative (day 1-3)
Patient reported health related quality of recovery (QoR-15)	Recovery is measured according to quality of recovery 15 score (QoR-15). The score ranges from 0-150. A high score indicates a good recovery.	Baseline and postoperative (day 1-3 and 14)
Mortality	Number of mortality obtained from medical charts	30 days
Heart rate variability	The heart rate will continuously recorded by ECG intra- and postoperatively	Postoperative (day 1-3)
Whole blood gene expression profiling	Gene mRNA transcript analysis	Baseline and postoperative (day 1-3)
Time to local cancer recurrence or metastatic spread	The two surgical methods will be compared in order to obtain any differences in the local or metastatic cancer recurrence	3 years postoperatively

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Region of Southern Denmark
• Investigators: Principal Investigator: Pedja Cuk, MD, Surgical Department, Hospital of Southern Jutland, Denmark

Publications and helpful links

General Publications

• Cuk P, Pedersen AK, Lambertsen KL, Mogensen CB, Nielsen MF, Helligso P, Gogenur I, Ellebaek MB. Systemic inflammatory response in robot-assisted and laparoscopic surgery for colon cancer (SIRIRALS): study protocol of a randomized controlled trial. BMC Surg. 2021 Oct 11;21(1):363. doi: 10.1186/s12893-021-01355-4.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (ACTUAL): December 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Laparoscopy; Systemic inflammatory response; Robotic assisted surgery; Colonic neoplasm
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Neoplasms; Neoplasms by Site; Peritoneal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Shock; Intestinal Neoplasms; Colorectal Neoplasms; Intraabdominal Infections; Inflammation; Peritonitis; Colonic Neoplasms; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: 75709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No